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For Companies At a Glance
- Tasks: Lead regulatory strategies for innovative diagnostics in a dynamic team environment.
- Company: Join Novartis, a global leader in healthcare dedicated to improving lives.
- Benefits: Enjoy flexible work options, professional development, and a commitment to diversity.
- Why this job: Be part of a passionate community driving breakthroughs that change lives.
- Qualifications: 2-4 years in diagnostics with a science-based degree; advanced degrees preferred.
- Other info: Collaborate with top professionals and contribute to impactful health solutions.
The predicted salary is between 43200 - 72000 £ per year.
The Regulatory Diagnostics Manager (RDM) for Precision Diagnostics is responsible for the implementation of strategic plans for diagnostics development, including companion diagnostics, related to Novartis's innovative medicines portfolio, including marketed products. The RDM collaborates with senior members of the RA Precision Diagnostics Team, including the TA and Diagnostics Lead, on strategies and submissions such as companion diagnostics. They work closely with internal RA Disease Unit associates, Digital, Data and Clinical Innovation (DDCI) at Novartis, and Partner Companies developing diagnostics, ensuring compliance with regulatory requirements. The RDM also provides regulatory support, including tactical and technical direction for clinical trial assays, to ensure regulatory compliance.
Major Accountabilities
- Supports diagnostics regulatory strategy for precision IVDs and CDx (e.g., US, EU, Japan, China).
- Responsible for submissions in premarket and post-market spaces, including IDE, Significant Risk Determinations, PsA, and pre-market authorization, with support from the RA TA and Diagnostics Lead.
- Ensures diagnostic regulatory input is incorporated into drug development strategies, meeting IVD, CDx, and LDT regulations.
- Partners with RA country organizations to align on local regulatory requirements and deliver timely submissions.
- Prepares, files, and coordinates briefing books for HA meetings related to diagnostics and CDx development.
- Develops and manages plans for responses to HA requests and follow-up activities.
- Participates as a member of RA subteam and BDST as appropriate.
Training and Compliance
- Supports compliance activities for clinical trials related to global regulations on diagnostics, ensuring regulatory compliance of Partner companies, and supports roll-out of new procedures and training.
Performance Indicators
- Successful implementation of regulatory strategies with timely submissions.
- Full compliance with IVD and LDT rules.
- Identification of diagnostic needs for Novartis programs.
- Strong partnership with RA Diagnostics Team and community adherence to policies.
Experiences & Skills
- Minimum 2-4 years of experience in diagnostics, IVD, or CDx development within the pharmaceutical industry.
- Science-based BS or MS; advanced degrees preferred.
- Proven experience in regulatory projects/submissions involving IVD/CDx.
- Understanding of IDE, MAA, NDA/BLA, 510(k), PMA submissions.
- Knowledge of assay validation and CLIA.
- Understanding of clinical trials.
- Strong interpersonal and negotiation skills.
Why Novartis
Helping people with disease and their families requires more than science. It takes a community of passionate, collaborative individuals like you. Join us to create breakthroughs that change lives.
Commitment To Diversity & Inclusion
Novartis is committed to building an inclusive, diverse work environment reflecting the communities we serve.
Benefits and Rewards
Discover how we support your growth.
Regulatory Diagnostics Manager employer: Novartis
Contact Detail:
Novartis Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Diagnostics Manager
✨Tip Number 1
Familiarise yourself with the latest regulations and guidelines related to diagnostics, IVDs, and CDx. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in this fast-evolving field.
✨Tip Number 2
Network with professionals in the regulatory affairs and diagnostics sectors. Attend industry conferences or webinars where you can meet potential colleagues from Novartis and learn more about their work culture and expectations.
✨Tip Number 3
Prepare to discuss specific examples of your past experiences with regulatory submissions and compliance. Highlight any successful projects you've led or contributed to, especially those involving IVD/CDx development.
✨Tip Number 4
Showcase your interpersonal and negotiation skills during the interview process. Be ready to provide scenarios where you've effectively collaborated with cross-functional teams, as this is crucial for the role at Novartis.
We think you need these skills to ace Regulatory Diagnostics Manager
Some tips for your application 🫡
Understand the Role: Take time to thoroughly read the job description for the Regulatory Diagnostics Manager position. Understand the key responsibilities and required skills, so you can tailor your application to highlight relevant experiences.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in diagnostics, IVD, or CDx development. Be specific about your previous roles and how they relate to the responsibilities outlined in the job description.
Showcase Your Skills: Make sure to showcase your interpersonal and negotiation skills, as well as your understanding of regulatory submissions like IDE, MAA, NDA/BLA, and 510(k). Use examples from your past work to demonstrate these abilities.
Craft a Compelling Cover Letter: Write a tailored cover letter that connects your background to Novartis's mission and values. Explain why you are passionate about the role and how you can contribute to their goals in precision diagnostics.
How to prepare for a job interview at Novartis
✨Understand the Regulatory Landscape
Familiarise yourself with the specific regulatory requirements for diagnostics, particularly IVDs and CDx. Be prepared to discuss your knowledge of IDE, MAA, NDA/BLA, and 510(k) submissions, as this will demonstrate your expertise in the field.
✨Showcase Your Collaborative Skills
Highlight your experience working with cross-functional teams, especially in a regulatory context. Discuss how you've partnered with various stakeholders, such as RA country organisations and clinical trial teams, to ensure compliance and timely submissions.
✨Prepare for Technical Questions
Expect technical questions related to assay validation and clinical trials. Brush up on your understanding of these processes and be ready to provide examples from your past experiences that showcase your problem-solving abilities.
✨Demonstrate Your Passion for Compliance
Express your commitment to regulatory compliance and how it impacts patient safety and product efficacy. Share any relevant experiences where you ensured adherence to regulations and contributed to successful project outcomes.
